Study Start Up Associate I (regulatory - Office With Flex)

ICON

Buenos Aires, Argentina
Hybrid
Knowledge of icon sops/wps and ich/gcp
Clinical trial start-up document management
Regulatory submission package assembly
As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations

Job Summary

  • As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.
  • ICON offers a diverse culture that rewards high performance and nurtures talent, providing competitive salary and benefits focused on well-being and work-life balance.
  • ICON is dedicated to providing an inclusive and accessible environment for all candidates and is committed to a workplace free of discrimination and harassment.

Matching Summary

As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.

Skills & Requirements

Must-have

  • Knowledge of ICON SOPs/WPs and ICH/GCP
  • Clinical trial start-up document management
  • Regulatory submission package assembly
  • Trial Master File (TMF) quality control
  • Fluent communication in English and Spanish

Nice-to-have

  • Ability to work independently in fast-paced environment
  • Strong attention to detail and organizational skills
  • Participation in internal study review meetings
  • Forecasting site activation plans accurately

Key Requirements

  • Bachelor’s Degree preferably in Life Sciences
  • 2 years’ experience or understanding of clinical study start-up
  • Knowledge of local and/or international regulatory processes
  • Ability to read and understand clinical protocols and regulatory documents

Work Rights

Not specified

Tailored Resume

Cover Letter